FDA Label for Eucalyptol, Menthol, Methyl Salicylate, Thymol

View Indications, Usage & Precautions

Eucalyptol, Menthol, Methyl Salicylate, Thymol Product Label

The following document was submitted to the FDA by the labeler of this product Demoulas Super Markets, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%


Purpose



Antigingivitis, antiplaque


Use



helps control plaque that leads to gingivitis


Warnings



for this product


Do Not Use



if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.


Stop Use And Ask A Dentist If



gingivitis, bleeding, or redness persists for more than 2 weeks


Keep Out Of Reach Of Children.



If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Directions



adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

children 6 years to under 12 years of age - supervise use

children under 6 years of age - do not use

  • this rinse is not intended to replace brushing or flossing

Other Information



cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-86°F)


Inactive Ingredients



 water, alcohol 21.6%, sorbitol, flavor, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, sodium saccharin, green 3


Other



This product is not manufactured or distributed by Johnson & Johnson Healthcare products, distributor of Listerine Ultraclean With Everfresh Technology - Cool Mint.

DISTRIBUTED BY

DEMOULAS SUPER MARKETS, INC.

875 East Street

TEWKSBURY, MA 01876


Principal Display Panel



"MORE FOR YOUR DOLLAR"

MARKET BASKET

Compare to Listerine Ultraclean Cool Mint*

TARTAR CONTROL PLUS

ANTISEPTIC

ANTIGINGIVITIS/ANTIPLAQUE

MOUTH RINSE

Blue Mint

Fights tartar build-up

better than

brushing alone

Sealed With Printed Neckband For Your Protection

1.5 L (50.7 FL OZ)


* Please review the disclaimer below.